Appendicular and rectal stimulator device for digestive and eating disorders

ABSTRACT

A method of treating a gastrointestinal disorder is disclosed. The method includes the step of applying a medium to an appendicular wall of a user to stimulate the enteric nervous system and thereby treat the gastrointestinal disorder.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present patent application is a divisional of the patent applicationidentified by U.S. Ser. No. 11/893,786, filed on Aug. 17, 2007, theentire content of which is hereby incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

NAMES OF PARTIES TO A JOINT RESEARCH AGREEMENT

Not applicable.

REFERENCE TO A “SEQUENCE LISTING”, A TABLE, OR A COMPUTER PROGRAMLISTING APPENDIX SUBMITTED ON A COMPACT DISC AND AN INCORPORATION BYREFERENCE OF THE MATERIAL ON THE COMPACT DISC

Not applicable.

BACKGROUND OF THE INVENTION

Electrical stimulation, or pacing, was advocated as a possible treatmentfor gastric motor dysfunction as early as 1963. Experimentation in thelate 1960s and early 1970s, began to demonstrate the significance ofgastrointestinal myoelectrical activity and its relation to contractileactivity.

Electrical stimulation has been shown to be able to alter, inhibit, orexcite gastrointestinal motor functions, activate intrinsic andextrinsic neuronal pathways and/or solicit hormonal/peptide releases.Because of these characteristics, electrical stimulation has been shownto be effective in normalizing gastric dysrhythmia, accelerating gastricemptying, and reducing symptoms such as nausea and vomiting. Recently,electrical stimulation has also been studied as a therapy for obesity.

Obesity is a growing public health problem with a lack of satisfactorytreatments. Recent research seems to suggest that electrical stimulationmay delay gastric emptying and thereby assist in prolonging mealintervals and reducing frequent snacking without the risks andcomplications of surgery. Fluid intake may also be induced by electricalstimulation so as to assist in reducing appetite, for example, byreducing the capacity for accommodating food within the gastrointestinaltract as detailed in “Therapeutic Potential of Duodenal ElectricalStimulation for Obesity: Acute Effects on Gastric Emptying and WaterIntake” by Shi Liu, Xiaohua Hou, and J. D. Z. Chen in American Journalof Gastroenterology, Volume 100, pages 792-796 (2005) that is herebyincorporated by reference in its entirety.

Most of the devices developed to provide for electrical stimulation arelocated within the gastric region of the gastrointestinal tract. SeeGASTROINTESTINAL PACEMAKER HAVING PHASED MULTIPOINT STIMULATION (U.S.Pat. No. 5,690,691), GASTROINTESTINAL ELECTRICAL STIMULATION (U.S. Pat.No. 6,826,428), SENSOR BASED GASTROINTESTINAL ELECTRICAL STIMULATION FORTHE TREATMENT OF OBESITY OR MOTILITY DISORDERS (U.S. Patent PublicationNo. 2005/0222638), PROCESS FOR ELECTROSTIMULATION TREATMENT OF MORBIDOBESITY (U.S. Patent Publication No. 2004/0088022), TACHYGASTRIALELECTRICAL STIMULATION (U.S. Patent Publication No. 2005/0222637), eachof which is hereby incorporated by reference in its entirety.

The enteric nervous system (ENS) contains numerous short axon andinter-neurons in the intestinal wall. The vast number of neurons andneuronal connections in the intestinal ENS carry out many digestivereflexes independent from the central nervous system. For example, thecomplex movements of peristalsis seen in the esophagus, stomach, andintestine are entirely initiated and regulated by the ENS. In addition,many neurotransmitters are released by ENS neurons to control glandularsecretion and muscle contraction in the gut wall. Research has shownthat stimulation in one area of the intestinal tract can providestimulation in a whole other area within the ENS system.

BRIEF SUMMARY OF THE INVENTION

In one embodiment, the present invention is related to a method of usinga stimulation device to emit a medium in the appendicular region fortreatment of a gastrointestinal disorder. In general, a stimulationdevice is inserted into the luminal cavity of the appendix and deliversthe medium for treatment of the gastrointestinal disorder or eatingdisorder. The stimulation device may be placed endoscopically and/orsurgically inserted into the appendix. For example, the stimulationdevice may be inserted into the cavity of the appendix using endoscopictechniques by placing the stimulation device in a pouch underneath theskin.

In one version, the stimulation device comprises at least two electrodessized and shaped for insertion into the mucosa or submucosa of theappendix. The electrodes are in communication with a pulse generatorlocated in the luminal cavity of the appendix. In another version, apair of stimulation electrodes are inserted into the seromuscular layerof the appendix and connected to a generator inserted subcutaneouslywithin the abdominal region.

In general, the pulse generator delivers pulses to the electrodeslocated in the mucosa and/or submucosa or serosa of the appendix suchthat the electrodes provide stimulation to the appendicular wall andthus the gastrointestinal tract through the enteric nervous system ofthe user. The pulses can be provided in a variety of different manners,such as intermittent pulses, continuous pulses, and/or a train ofintermittent and/or continuous pulses. Such pulses can be delivered viathe pulse generator to the electrodes via any suitable medium, such aselectricity, acoustic waves, radiation, photons, or the like.

The method provides treatment for several gastrointestinal diseases anddisorders. For example, the method may be used in the treatment ofdyspepsia, postoperative ileus, irritable bowel syndrome, constipation,diarrhea, fecal incontinence, pain and discomfort associated withvisceral organs, obstructed intestines, eating disorders includingobesity, nausea and/or emesis, including chemotherapy-induced emesis.

In one version, the method further includes the step of programming acontroller in communication with the pulse generator with a stimulationparameter. The controller is located either external and/or internal tothe body. The controller can communicate with the pulse generator viaany suitable manner such as leads, electromagnetic waves, inductivecoupling, or the like. In one preferred embodiment, the controllerelectromagnetically controls the pulse generator.

Preferably, the controller is programmed with a stimulation parametereither prior to or subsequent to insertion of the stimulation device inthe appendix. The stimulation parameter is utilized by the controller tocontrol the stimulation device such that the stimulation device deliverspredetermined types of pulses to the submucosa of the appendix.Stimulation parameters can include frequency, pulse width, amplitude,and the like. It should be understood that the stimulation parametersutilized to control the controller can be modified according to thedesires of the designer and/or the user.

In one version, the stimulation device is further provided with a sensorsystem for detecting environmental conditions around the stimulationdevice or any part of the gastrointestinal tract. The environmentalconditions can be used to determine parameters regarding the externalenvironment of the stimulation device when inserted in the appendix.Information received from the sensor system can provide feedback to helpcontrol the stimulation device. The sensor system can include one ormore sensors for sensing a variety of different types of environmentalfactors which may be surrounding the stimulation device or thegastrointestinal tract such as, for example, mechanical contractions,pressure, tension, electrical signals, temperature, pH or the like.

In another version, the stimulation device is further provided with apower source for supplying power to the stimulation device. The powersource can be implemented in a variety of manners, such as a batterysupported by the stimulation device, or a separate device providedexternal to the user which provides power to the stimulation devicethrough a wireless mechanism, such as inductive loop coupling.

In another aspect, the present invention is directed to a method ofusing a stimulation device to emit a medium to the rectum for treatmentof a gastrointestinal disorder and/or eating disorder. In general, thestimulation device is inserted into the internal wall of the rectum. Themedium is delivered, via the stimulation device, to the rectum for thetreatment of the gastrointestinal disorder and/or eating disorder.

In another aspect, the present invention is directed to a stimulatordevice for emitting a medium to the gastrointestinal tract of a user. Ingeneral, the stimulator device is comprised of at least two electrodessized and shaped for insertion into the mucosa, submucosa or serosa ofthe appendix of the user. The electrodes supply the medium to theappendix. Additionally, a pulse generator, for delivering pulses of themedium to the electrodes, is placed subcutaneously in the user.Additionally, a controller, in communication with the pulse generator,controls the pulses. Preferably, the electrodes, pulse generator, andcontroller are supported by a housing.

In another aspect, the present invention is directed to a deliverysystem for providing a stimulator device to the appendix. In general,the delivery system includes an elongated tubular member having a distalend adapted for insertion into an anal orifice. A stimulator device issupported by the elongated tubular member and deployed in theappendicular area. The stimulator device includes a housing constructedof a bio-compatible non-digestible material; a pulse generator disposedin the housing for generating pulses; a controller disposed incommunication with the pulse generator for controlling the pulses; and,at least two electrodes supplying a medium containing the pulsesgenerated by the pulse generator to the gastrointestinal tract.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

So that the above recited features and advantages of the presentinvention can be understood in detail, a more particular description ofthe invention, briefly summarized above, may be had by reference to theembodiments thereof that are illustrated in the appended drawings. It isto be noted however that the appended drawings illustrate only typicalembodiments of the invention and are therefore not to be consideredlimiting of its scope, for the invention may admit to other equallyeffective embodiments.

FIG. 1A is a diagrammatic view of lower digestive system including theappendicular region and rectal region.

FIG. 1B is a schematic block diagram view of one embodiment of astimulator device positioned in the appendicular region in accordancewith the present invention.

FIG. 1C is a diagrammatic view of another embodiment of a stimulatordevice positioned in the appendicular region in accordance with thepresent invention.

FIG. 1D is a diagrammatic view of another embodiment of a stimulatordevice positioned in the rectal region in accordance with the presentinvention.

FIG. 1E is a diagrammatic view of another embodiment of a stimulatordevice positioned in the rectal region in accordance with the presentinvention.

FIG. 2 is a diagrammatic view of the embodiment of the stimulator deviceillustrated in FIG. 1C and FIG. 1D constructed in accordance with thepresent invention.

FIG. 3 is a schematic, block diagram of another embodiment of astimulator device constructed in accordance with the present invention.

FIGS. 4 a-4 e illustrate a variety of exemplary pulses which can begenerated by a stimulator devices for treating a variety of types ofgastrointestinal disorders.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Present embodiments of the invention are shown in the above-identifiedfigures and described in detail below. In describing the embodiments,like or identical reference numerals are used to identify common orsimilar elements. The figures are not necessarily to scale and certainfeatures in certain views of the figures may be shown exaggerated inscale or in schematic in the interest of clarity and conciseness. Pleaseadd/modify explanations of figures based on my addition and changes tothe figures.

Referring now to the drawings, and in particular to FIGS. 1A-1E, showntherein and designated by reference numeral 10 is a stimulator device(hereinafter referred to as “stimulator device”), constructed inaccordance with the present invention, for providing stimulation to agastrointestinal tract 12 of a user 14. The gastrointestinal tract 12 ofthe user 14 includes the alimentary canal and organs associated with thealimentary canal such as the stomach, small intestine, large intestine,and the like. Users 14 may include humans, mammals, or othermulticellular organism having a gastrointestinal tract 12.

In general, the stimulator device 10 is placed in the appendix or withinan appendicular region 16 and/or rectal region 18 of a lower digestivetract 17 of the user 14. The vermiform appendix is located at thejunction of the small intestine and the large intestine. The appendix isgenerally credited with no significant function and is most commonlyexplained as a vestigial structure within the body. It is routinelyremoved without any ill effects or side effects. However, the linkage ofthe appendix within the ENS to the gastrointestinal tract 12 provides anavenue for electrical stimulation in the treatment of gastrointestinaldisorders giving a desirable use and purpose for this vestigialstructure.

The rectum is also linked within the ENS to the gastrointestinal tract12 and offers another option for convenient placement of the stimulatordevice 10. Specifically, the relative proximity of the anal orifice tothe rectum allows placement of the stimulator device 10 in the rectumwithout the need for extensive surgical procedures currently practicedin gastrointestinal stimulator placement.

Preferably, at least a portion of the stimulator device 10 is placed incontact with the appendicular wall 20 and/or rectal wall 22 of the user14. The stimulator device 10 may contact the external appendicular wall20 and/or rectal wall 22, the interior appendicular wall 20 and/orrectal wall 22, and/or be within the appendicular wall 20 and/or rectalwall 22. For example, the stimulator device may be placed in contactwith the mucosal surface, underlying vascular submucosa, serosa, and/orlayered muscularis externa of the appendicular wall 20 and/or rectalwall 22. Preferably, the stimulator device 10 is inserted into thesubmucosa of the appendicular wall 20 and/or rectal wall 22.

Optionally, the stimulator device 10 may be attached to the appendicularwall 20 and/or rectal wall 22 to prevent migration of the stimulatordevice 10 through the gastrointestinal tract 12. The stimulator device10 may be attached to the appendicular wall 20 and/or rectal wall 22through the use of projections, barbs, umbrella connectors, sutures,adhesives, and/or the like. Additionally, multiple stimulator devices 10may be placed within the user 14. For example, the user 14 may have afirst stimulator device 10 within the appendicular region 16 and asecond stimulator device 10 within the rectal region 18 of the user 14.

Once positioned in contact with the appendicular wall 20 and/or rectalwall 22, the stimulator device 10 delivers pulses of a medium andprovides stimulation to the gastrointestinal tract 12 through theenteric nervous system. Placement of the stimulator device 10 within onearea of the enteric nervous system provides stimulation not only at thearea of contact, but also provides stimulation within other areas of theENS system. For example, placement of the stimulator device 10 withinthe appendicular region 16 can provide stimulation initiatingperistaltic activity within the gastrointestinal tract 12.

Stimulation of the gastrointestinal tract 12 through the enteric systemwill alter, inhibit, or excite gastrointestinal motor functions,activate intrinsic and extrinsic neuronal pathways and/or solicithormonal/peptide releases. The effects of stimulation on thesefunctions/pathways are related to the selection of stimulationparameters which are discussed in greater detail below and havetherapeutic potentials for various diseases/disorders. The stimulatordevice 10 can thus be used for treating a variety of digestive andeating disorders as well as in use in treating chemotherapy-inducedemesis. Exemplary eating disorders include obesity, binging, bulimia,and the like. Gastrointestinal disorders include dysphagia,gastroesophageal reflux diseases, functional dyspepsia, gastroparesis,postoperative ileus, irritable bowel syndrome, constipation, diarrhea,fecal incontinence, pain/discomfort, nausea and vomiting, and the like.

The stimulator device 10 can be programmed with stimulation parametersprior to placement of the stimulator device 10 within the appendicularregion 16 and/or rectal region 18 of the user 14 so that a particulardisease or disorder will be treated. A health care provider or user maybe presented with a variety of stimulator devices 10 with eachstimulator device 10 pre-programmed to treat a different disorder.Alternatively, the stimulator device 10 can be programmed to treat aparticular disorder immediately prior to administration. Alternatively,the stimulator device 10 can be programmed with a variety of differenttypes of treatment regimens for different diseases and/or disorders sothat the stimuli can be changed during treatment of the gastrointestinaldisorder without need for the removal of the stimulator device 10.

As illustrated in FIGS. 1B and 1E, the stimulator device 10 includes atleast two electrodes 26 and 28 in communication with a pulse generator30. The electrodes 26 and 28 can be provided as one or multiple pairsand in varying shapes. For example, the electrodes 26 and/or 28 can beprovided as a point electrode, a ring electrode, or a patch electrode.

The electrodes 26 and 28 may be surgically implanted or insertablyplaced within the appendicular region 16 and/or rectal region 18. Forexample, for the placement of stimulator into the appendix or rectum,colonoscopy or endoscopy can be utilized. For the placement ofstimulator in other areas, various surgical techniques may be useddepending on the location of placement. For example, both traditionalsurgical techniques and/or laparoscopic techniques may be used inplacing the stimulator device 10 in the appendicular region 16 and/orrectal region 18. Preferably, laproscopic techniques, using smallincisions in comparison to large incisions of traditional surgery, areused to place the stimulator device 10. Additionally, other forms ofsurgical placement, known now or developed within the future, may beused as long as the stimulation device is placed in contact with theappendicular wall 20 and/or rectal wall 22 of the user 14.

The electrodes 26 and 28 are in communication with the pulse generator30 such that pulses can be provided from the pulse generator 30 to theelectrodes 26 and 28. The pulse generator delivers a frequency of pulsesto the electrodes 26 and 28 providing emission of the medium to theappendicular wall 20 and/or rectal wall 22. For example, the pulsegenerator 30 delivers pulses to the electrodes 26 and 28 in contact withthe appendicular wall 20 such that the electrodes 26 and 28 providestimulation to the gastrointestinal tract 12 of the user 14 through theenteric nervous system.

The pulses provided by the pulse generator 30 to the electrodes 26 and28 can be provided in a variety of different manners, such asintermittent pulses, continuous pulses, and/or a train of intermittentand/or continuous pulses. Selection of the pulses is determined based onthe particular gastrointestinal disease(s) and/or disorder(s) beingtreated as described in more detail below.

Such pulses can be delivered via the pulse generator 30 to theelectrodes 26 and 28 via any suitable medium, such as electricity,acoustic waves, radiation, photons, or the like. Preferably, the mediumis in the form of electrical stimulation to the appendicular wall 20and/or rectal wall 22.

The pulse generator 30 adjacent to the electrodes 26 and 28 or separatefrom the electrodes 26 and 28. In one embodiment, the pulse generator 30is separate from the electrodes 26 and 28 and inserted subcutaneouslywithin the abdominal region. Preferably, the pulse generator 30 isinserted subcutaneously within the abdominal region above the belt lineof the user 14. In another embodiment, as illustrated in FIGS. 1C and1D, the pulse generator 30 is adjacent to the electrodes 26 and 28.

Additionally, pulse generator 10 may utilize an internal power source oran external power source. It is contemplated that the power source maybe located external to the user 14, provided the power source is incommunication with the pulse generator 30. For example, the power sourcemay be provided external to the user 14 through a wireless mechanism,such as inductive loop coupling, electromagnetic control, or the like.

The stimulator device may optionally include a controller 32. Thecontroller 32 communicates with the pulse generator 30 for controllingthe pulses generated by the pulse generator 30. The controller 32 can beanalog, digital, or a combination of both. The controller 32 may be acomputer, a microcontroller, a microprocessor, or the like.

The controller 32 uses stimulation parameters to regulate the pulsegenerator 30 and provide a variety of different types of treatmentregimens for different diseases and/or disorders. Stimulationparameters, as discussed in more detail below, may include frequency,pulse width, amplitude, and the like. Programming of the controller 32can regulate pulses generated by the pulse generator 30 so that can thepulses change based upon the treatment regime for the user 14. Thecontroller 32 may be programmed with stimulation parameters prior toinsertion and/or placement of the stimulator device 10 and/or afterinsertion and/or placement of the stimulator device 10.

Shown in FIG. 2 is a diagrammatic view of one example of the stimulatordevice illustrated in FIG. 1C and FIG. 1D constructed in accordance withthe present invention. The stimulator device 10 is provided with twoelectrodes 26 and 28, the pulse generator 30, and the controller 32.Additionally, the stimulator device includes a housing 34 and a powersource 36.

The housing 34 is constructed of a biocompatible, non-digestiblematerial for use within the appendicular region 16 and/or the rectalregion 18 of the user 14. Examples of biocompatible, non-digestiblematerials suitable for use in forming the housing 34 are, but notlimited to, biocompatible metals, such as unalloyed titanium, wroughttitanium alloy, nitrogen austenitic steel, stainless steel, andbiocompatible plastic such as polyvinylchloride,polytetrafluoroethelyne, polyethersulfone, polyurethane, polycarbonate,polyetheretherketone and polypropylene.

The housing 34 is sized and shaped for placement within the appendicularregion 16 and/or rectal region 18. Preferably, the housing is sized andshaped for transport through the anal orifice. For example, the housing34 can be shaped in the form of a capsule. However, it should beunderstood that the housing 34 can be provided in other shapes and/orsizes, so long as the housing 34 can be inserted through the analorifice and/or placed in at least a portion of the appendicular region16 and/or rectal region 18 preferably without causing any negative sideeffects, such as irritation. It is also desirable for the housing 34 tobe sized and shaped so as not to block the appendicular region 16 and/orrectal region 18 leading to interference with the operation of thegastrointestinal tract 12. Further, it should be understood that ratherthan simply being constructed of a biocompatible, non-digestiblematerial, the housing 34 can be formed of a non-biocompatible, or evendigestible material that is coated with a biocompatible non-digestiblematerial.

The housing 34 is formed with the electrodes 26 and 28 separated by aninsulating material 38. The electrodes 26 and 28 are connected to theinsulating material 38 so as to form a sealed container. The housing 34defines an interior space containing the pulse generator 30, thecontroller 32, and the power source 36. However, it should be understoodthat at least the power source 36, and the controller 32 can be externalto the housing 34 so long as the power source 36 and/or controller 32can communicate and/or provide power, and/or control to the pulsegenerator 30.

As discussed above, the controller 32 communicates with the pulsegenerator 30 for controlling the pulses generated by the pulse generator30. The electrodes 26 and 28 supply a medium containing the pulsesgenerated by the pulse generator 30 to the appendicular wall 20 and/orrectal wall 22. As discussed above, the medium can be provided in avariety of forms such as electricity, acoustic waves, radiation,photons, or the like.

The electrodes 26 and 28 can be provided as one or multiple pairs andcan be provided on the housing 34 in various locations and differentshapes. For example, the electrodes 26 and/or 28 can be provided as apoint electrode, a ring electrode, or a patch electrode. The distancebetween the electrodes 26 and 28 in a pair can also vary.

As shown in FIG. 2, the controller 32 is supported by the housing 34 andis contained within the interior space of the housing 34. The controller32 can be external to the housing 34 or at least portions of thecontroller 32 can be external to the housing 34 so long as thecontroller 32 can communicate with and/or control the pulse generator30.

The power source 36 is also supported by the housing 34. Preferably, thepower source 36 is within the internal space of the housing 34. However,it is contemplated that the power source 36 may be located external tothe housing 34, provided the power source 36 is in communication withthe pulse generator 30 and/or the controller 32. For example, the powersource 36 may be provided external to the user 14 through a wirelessmechanism, such as inductive loop coupling, electromagnetic control, orthe like.

The housing 34 may optionally include means for attaching the stimulatordevice 10 to the appendicular wall 20 and/or rectal wall 22. Aspreviously discussed, attachment means include, but are not limited to,projections, barbs, umbrella connectors, sutures, adhesives, and/or thelike.

Referring to FIG. 3, regulation of the pulse generator 30 by thecontroller 32 may include an open-loop system 40, a closed loop system42, or a combination of the like. In the open loop system 40, pulses aredelivered to the electrodes 26 and 28 without the use of sensing inputssuch as a sensor system 44. In the closed loop system 42, pulses aredelivered to the electrodes 26 and 28 based on inputs to the controller32 via the sensor system 44. For example, the sensor system 44 candeliver electrical signals to the controller 32 that vary or areindicative of the following conditions: mechanical contractions,pressure, tension, electrical signals, temperature, pH or the like.Although FIG. 3 shows the controller 32, it should be noted thestimulator device 10 may include the pulse generator 30 supplying pulsesto the electrodes 26 and 28 without the use of the controller 32.

One embodiment of the open loop system 40 includes the controller 32,the pulse generator 30, and the electrodes 26 and 28. The controller 32is in communication with the pulse generator 30 and regulates pulsesgenerated by the pulse generator 30. The pulse generator 30 provides thepulses to the electrodes 26 and 28. The controller 32 may optionallycontain a timing mechanism, such as an internal clock, for furthercontrolling the pulses. In another embodiment (not illustrated), thecontroller 32 is in direct communication with the electrodes 26 and 28directly and alters the pulses supplied to the electrodes 26 and 28directly.

The closed-loop system 42, as illustrated in FIG. 3, includes thecontroller 32, the pulse generator 30, the electrodes 26 and 28, and thesensor system 44. The sensor system 44 communicates with the controller32 and detects environmental conditions external to the stimulatordevice 10. The environmental conditions can be used to determine thelocation of the stimulator device 10 within the gastrointestinal tract12 of the user 14 if the stimulator device 10 migrates. Additionally theenvironmental conditions can be used to vary the frequency and/orintensity of the pulses generated by the pulse generator 30 as needed.The sensor system 44 can include one or more sensors for sensing avariety of different types of environmental factors which may besurrounding the stimulator device 10. For example, mechanicalcontractions, pressure, tension, electrical signals, temperature, pH orthe like.

The information received from the sensor system 44 is fed back to thecontroller 32 so that the controller 32 can vary stimulation parametersand regulate pulses generated by the pulse generator 30. For example,the sensor system 44 can detect the effect of stimulation to theappendicular region 16 and/or rectal region 18. The location or effectof the stimulator device 12 within the user 14 is fed back to thecontroller 32. The controller 32 then regulates the frequency, duration,and/or amplitude of the pulses generated by the pulse generator 30 basedon the effect of the stimulator device 10 within the appendicular region16 and/or rectal region 18 of the user 14.

The sensor system 44 can also provide a method for synchronizedstimulation such that pulses can be provided to the appendicular region16 and/or rectal region 18 of the user 14 upon detection by the sensorsystem 44 of a mechanical contraction within the user 14. Synchronizingeach pulse with the intrinsic physiological activity of the user 14 mayenhance gastrointestinal contractions and accelerate transport ofnutrients along the gastrointestinal tract.

As illustrated in FIG. 3, the stimulator device 10 may optionallyinclude a telemetry system 46 that assists in providing externalcontrol, external programming, and/or permitting measurement andreporting of information regarding the stimulator device 10 and/or theenvironmental conditions surrounding the stimulator device 10. Thetelemetry system provides communication between an internal controller,located within the user 14 such as the sensor system 44 and/orcontroller 32, while an external controller 48 is external to user. Theexternal controller 48 can be either proximally located to the user 14or located at a distance to the user 14 so long as the telemetry systemcan provide communication between the internal controller, such as thesensor system 44 and/or controller 32, and the external controller 48.The communication can be through radio frequency, infrared light, laserlight, visible light, acoustic energy, or the like. Both the internalcontroller, such as the sensor system 44 and/or controller 32, andexternal controller 48 are preprogrammed to provide monitoring,alerting, transmitting, and/or record-keeping of information generatedand/or needed for the stimulator device 10.

In one embodiment, communication between the sensor system 44, as theinternal controller, and a microprocessor, as the external controller48, provides monitoring of environmental information surrounding thestimulator device 10 and provides an alerting function if themicroprocessor and/or sensor system 44 detect abnormal conditions withinthe appendicular region 16 and/or rectal region 18 of the user 14. Inanother embodiment, communication between the sensor system 44, as theinternal controller, and the microprocessor, as the external controller48, allows for the analysis of the environmental information using adecision-making algorithm to provide stimulation parameters. Theenvironmental information is provided by the sensor system 44 andcommunicated by the telemetry system 46 to the microprocessor. Themicroprocessor uses the algorithm to determine the stimulationparameters. Such stimulation parameters are communicated again throughthe telemetry system 46 to either the controller 32 and/or sensor system44 to regulate the pulses generated by the pulse generator 30.

As previously discussed, stimulation parameters are utilized by thecontroller 32 to control the pulse generator 30. Stimulation parameterscan include frequency, pulse width, amplitude, and the like. The pulsesmay be intermittent pulses, continuous pulses, and/or trains ofintermittent and/or continuous pulses. The controller 32 can vary thestimulation parameters to provide variations in the pulses such that thepulse generator 32 provides long-pulse, short-pulse, dual phase pulses,trains of short-pulses, biphasic trains of pulses, or other variation ofpulses. FIGS. 4 a-e graphically illustrates the relative duration andamplitude of a variety of the exemplary pulses which can be generated bya pulse generator 30 based on the various stimulation parametersprovided by the controller 32. It should be understood that thestimulation parameters utilized by the controller 32 can be modifiedaccording to the desires of the designer and/or the patient.

FIG. 4 a graphically illustrates repetitive long-pulses having a pulsewidth in the order of milliseconds. The long pulse method is able to‘pace’ or entrain natural slow waves of the digestive tract. In thismethod, the electrical stimulus is composed of repetitive single pulseswith a pulse width in the order of milliseconds and a stimulationfrequency in the vicinity of the physiological frequency of the gastricslow wave as detailed in the article “Systematic review: applicationsand future of gastric electrical stimulation” by J. Zhang and J. D. Z.Chen in Alimentary Pharmacology & Therapeutics, Volume 24, pages991-1002 (2006) that is hereby incorporated by reference in itsentirety.

FIG. 4 b graphically illustrates repetitive short pulses having a pulsewidth that is substantially shorter than the long pulse of FIG. 4 a andis in the order of a few hundred microseconds as opposed tomilliseconds. The stimulation frequency is usually a few times higher orsubstantially higher than the physiological frequency of the gastricslow wave.

FIG. 4 c graphically illustrates the combining of short pulses and longpulses into a dual phase pulsing. This repetitive pulsing method iscomposed of one short pulse, or a multitude of short pulses, in theorder of a few hundred microseconds, followed by a long pulse, in theorder of a few hundred millisecond. Dual phase pulsing has been shown toprovide normalizing of gastric dysrhythmia and improvement in thesymptoms such as nausea and vomiting. Alternatively, dual phase pulsingmay include a long pulse followed by a short pulse, or othercombinations of long and short pulses.

FIG. 4 d graphically illustrates repetitive trains of pulses derivedfrom the combination of two signals. The first signal is a continuousshort pulse with a high frequency. The second signal is a control signalto turn the pulses on and off. For example, the second signal cancontain a stimulation parameter providing that the duration of the pulseis ‘on’ for x seconds and ‘off’ for y seconds. The addition of x and ycan then determine the frequency of the pulse train. This kind ofstimulation is frequently used in nerve stimulation and other relatedareas. It should be understood that trains of pulses can include trainsof short-pulses, trains of long-pulses, and/or a combination of the bothlong and short pulses.

FIG. 4 e graphically illustrates biphasic trains of pulses in whichpulse pairs are repeatedly symmetrically generated. The first pulse ofeach pair has a positive amplitude and the second pulse of each pair hasa negative amplitude. Similar to FIG. 4 d, pulses are repeatedlygenerated from the combination of two signals. The first signal includescontinuous pulse pairs that are repeatedly symmetrically generated. Thesecond signal is a control signal to turn the pulses on and off. Forexample, the second signal can contain a stimulation parameter providingthat the duration of the pulse is ‘on’ for x seconds and ‘off’ for yseconds. The addition of x and y can then determine the frequency of thepulse train.

It is contemplated, that in certain applications, it may be beneficialto vary the pulses during treatment of the gastrointestinal disorder orin the treatment of multiple disorders. For example, short pulses may beused if the device is used for treating disorders associated with thenervous systems such as pain, nausea and vomiting, long pulses or trainof pulses may be used if the device is used for treating disordersassociated with the movement of nutrient through the gastrointestinaltract, such as obesity or impaired gastrointestinal motility; acombination of short and long pulses will be used if the device is usedto treat disorders affected by both the nervous systems andgastrointestinal motility. Additionally, although a particular pulse maybe used by stimulator device 10, it may be beneficial to vary theamplitude, frequency, and/or duration of the pulse depending on locationof the stimulator device 10.

As discussed above, the stimulator device 10 is used to emit a mediumfor treatment of eating disorders such as obesity or a gastrointestinaldisorder or disease, such as dysphagia, gastroesophageal refluxdiseases, functional dyspepsia, gastroparesis, postoperative ileus,irritable bowel syndrome, constipation, diarrhea, fecal incontinence,pain/discomfort, nausea and vomiting, obesity, eating disorders as wellas in the treatment of chemotherapy-induced emesis.

In general, use of the stimulator device 10 includes providing thestimulator device 10 to the user 14. The stimulator device 10 is placedin the gastrointestinal tract 12 of the user 14. Methods ofadministering the stimulator device 10 include placement of thestimulator device within the appendicular region 16 and/or rectal region18 of the user 14 such as through traditional surgical procedures,laparoscopic procedures, and the like.

Additionally, methods of administering the stimulator device 10 mayinclude non-surgical methods such as insertion of the stimulator device10 into the anal orifice of the user through the use of a deliverycatheter. The delivery catheter includes an elongated tubular memberhaving at least one end adapted for insertion into the anal orifice. Thestimulator device 10 is supported by the elongated tubular member fordeployment within the appendicular region 16 and/or rectal region 18.

Once the stimulator device 10 is in contact with the appendicular wall20 and/or rectal wall 22, the stimulator device 10 delivers pulses ofthe medium for treatment of gastrointestinal diseases and/or disorders.Such pulses can be intermittent pulses, continuous pulses, and/or trainsof intermittent and/or continuous pulses as discussed previously.

It is contemplated that the stimulator device 10 may be distributed in avariety of methods. One method of distribution may include providing thestimulator device 10 to the user 14 by a medical professional. Forexample, a pharmaceutical distributor can distribute the stimulatordevice 10 to a medical professional for use in treating gastrointestinaldisorders, diseases, and/or for use in chemotherapy-induced emesis.Alternatively, the stimulator device 10 can be distributed to a pharmacyand/or provided to a retailer for over-the-counter distribution to auser 14 for use in treating gastrointestinal disorders, diseases and/orfor use in chemotherapy-induced emesis as well as obesity. The pharmacyand/or retailer may then sell the stimulator device 10 directly to theuser 14. Additionally, the stimulator device 10 may be provided in a kitcontaining the delivery catheter.

The foregoing disclosure includes the best mode for practicing theinvention. It is apparent, however, that those skilled in the relevantart will recognize variations of the invention that are not describedherein. While the invention is defined by the appended claims, theinvention is not limited to the literal meaning of the claims, but alsoincludes these variations.

1. A method of treating a gastrointestinal disorder, comprising the stepof: applying a medium to an appendicular wall of a user to stimulate theenteric nervous system and thereby treat the gastrointestinal disorder.2. A method of using a stimulation device to emit a medium to a rectumfor treatment of a gastrointestinal disorder, comprising the steps of:inserting the stimulation device into the internal wall of the rectum,the stimulation device including a housing in the form of a capsule;attaching the stimulation device to the internal wall of the rectum;and, delivering, by the stimulation device, the medium to the internalwall for the treatment of the gastrointestinal disorder.
 3. A stimulatordevice for emitting a medium to the appendix of a user for the treatmentof a gastrointestinal disorder comprising: at least two electrodes sizedand shaped for insertion into submucosa of the appendix of the user, theelectrodes supplying the medium to the appendix; a pulse generator sizedand shaped to be inserted subcutaneously into a user for generatingpulses of the medium to the electrodes; a controller disposed incommunication with the pulse generator for controlling the pulses.